Drug Delivery Infusion Systems - Medical Devices Pipeline Assessment, 2017

Published : Oct-2017

No. of Pages : 311

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1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 8
1.2 List of Figures 12
2 Introduction 13
2.1 Drug Delivery Infusion Systems Overview 13
3 Products under Development 15
3.1 Drug Delivery Infusion Systems - Pipeline Products by Stage of Development 15
3.2 Drug Delivery Infusion Systems - Pipeline Products by Segment 16
3.3 Drug Delivery Infusion Systems - Pipeline Products by Territory 17
3.4 Drug Delivery Infusion Systems - Pipeline Products by Regulatory Path 18
3.5 Drug Delivery Infusion Systems - Pipeline Products by Estimated Approval Date 19
3.6 Drug Delivery Infusion Systems - Ongoing Clinical Trials 20
4 Drug Delivery Infusion Systems - Pipeline Products under Development by Companies 21
4.1 Drug Delivery Infusion Systems Companies - Pipeline Products by Stage of Development 21
4.2 Drug Delivery Infusion Systems - Pipeline Products by Stage of Development 24
5 Drug Delivery Infusion Systems Companies and Product Overview 26
5.1 410 Medical Inc Company Overview 26
5.2 Acuros GmbH Company Overview 27
5.3 Adept Medical Ltd Company Overview 28
5.4 AktiVax Inc. Company Overview 29
5.5 Alnylam Pharmaceuticals Inc Company Overview 30
5.6 AngioDynamics Inc Company Overview 31
5.7 Automedics Medical Systems Inc (Inactive) Company Overview 34
5.8 Baxter International Inc Company Overview 35
5.9 Becton Dickinson and Co Company Overview 36
5.10 BioCardia Inc Company Overview 37
5.11 BioQ Pharma Inc Company Overview 40
5.12 ClearLine MD Company Overview 43
5.13 Debiotech SA Company Overview 44
5.14 Edwards Lifesciences Corp Company Overview 45
5.15 Eksigent Technologies LLC Company Overview 46
5.16 Elcam Medical Company Overview 48
5.17 Eli Lilly and Co Company Overview 49
5.18 EryDel SPA Company Overview 50
5.19 Flowonix Medical Inc Company Overview 53
5.20 FluidSynchrony, LLC Company Overview 57
5.21 Fluonic, Inc. Company Overview 58
5.22 Fresenius Kidney Care Company Overview 59
5.23 Hospira Inc Company Overview 60
5.24 Imagnus Biomedical Inc. Company Overview 61
5.25 Innovfusion Pte. Ltd. Company Overview 62
5.26 Intarcia Therapeutics Inc Company Overview 65
5.27 IRadimed Corp Company Overview 68
5.28 Ivenix Inc Company Overview 69
5.29 LifeMedix, LLC Company Overview 70
5.30 Lynntech Inc Company Overview 71
5.31 Massachusetts Institute of Technology Company Overview 72
5.32 Medallion Therapeutics, Inc. Company Overview 73
5.33 Medical Device Creations Ltd. Company Overview 74
5.34 MedPrime Technologies Pvt. Ltd. Company Overview 75
5.35 Medtronic plc Company Overview 76
5.36 Nano Precision Medical Inc Company Overview 77
5.37 NexGen Medical Systems Inc Company Overview 78
5.38 Nipro Corp Company Overview 79
5.39 Owen Mumford Ltd Company Overview 80
5.40 Pavmed Inc Company Overview 81
5.41 PRO-IV Medical Ltd Company Overview 82
5.42 Ratio Inc Company Overview 83
5.43 Rice University Company Overview 84
5.44 SC Pharmaceuticals Inc Company Overview 85
5.45 SteadyMed Therapeutics Inc Company Overview 86
5.46 StnDrd Infusion Corporation Company Overview 89
5.47 Surefire Medical Inc Company Overview 91
5.48 Tandem Diabetes Care Inc Company Overview 95
5.49 Terumo Corp Company Overview 96
5.50 ToucheMedical Ltd. Company Overview 98
5.51 Turnpoint Medical Devices Inc Company Overview 99
5.52 Unilife Corporation Company Overview 100
5.53 University of Minnesota Company Overview 101
5.54 University of Southern California Company Overview 102
5.55 vTitan Corporation Pvt Ltd Company Overview 103
6 Drug Delivery Infusion Systems- Recent Developments 105
6.1 Sep 15, 2017: New Intarcia Study Evaluates Optimal Way to Switch from Daily Liraglutide Injections to ITCA 650 in Patients with Type 2 Diabetes 105
6.2 Sep 11, 2017: MPSC Achieves Substantial Growth in 1H 2017 Net Profit Increases 272.4% YOY 106
6.3 Sep 08, 2017: Fresenius Kabi marks 20-year anniversary of Friedberg production site - Logistics center expansion planned 107
6.4 Sep 07, 2017: Lilly Takes Steps To Streamline Business, Invest In New Medicines And Drive Growth 108
6.5 Sep 05, 2017: RMS Receives FDA Clearance for 510(k) 109
6.6 Aug 31, 2017: Admedus Financial Results For The Year Ended 30 June 2017 110
6.7 Aug 30, 2017: Smiths Medical Receives FDA 510(k) Clearance on Wireless Ambulatory Infusion Pump 112
6.8 Aug 30, 2017: Ablative Solutions Announces Presentation at the Baird Global Healthcare Conference 113
6.9 Aug 24, 2017: Tandem Diabetes Care Announces Issuance of Patent Related to Remote Bolus Feature for Medical Infusion Pumps 113
6.10 Aug 22, 2017: Medtronic Reports First Quarter Financial Results 114
6.11 Aug 15, 2017: Changes in Novo Nordisk Executive Management 116
6.12 Aug 14, 2017: MicroPort Lifesciences Hosts GnRH Pump Treatment Symposium 117
6.13 Aug 14, 2017: ConvaTec appoints two Non-Executive Directors 118
6.14 Aug 14, 2017: PAVmed Reports Second Quarter 2017 Financial Results 119
6.15 Aug 11, 2017: MPSC Issues Positive Profit Alert for 2017 1H Net Profit Expected to Increase 261% 120
6.16 Aug 11, 2017: SteadyMed Reports Second Quarter 2017 Financial Results and Provides Corporate Update 120
6.17 Aug 09, 2017: Novo Nordisk increased reported operating profit by 8% in the first six months of 2017 122
6.18 Aug 09, 2017: Alnylam Pharmaceuticals Reports Second Quarter 2017 Financial Results and Highlights Recent Period Activity 123
6.19 Aug 08, 2017: DURECT Announces Second Quarter 2017 Financial Results and Provides Corporate Update 124
6.20 Aug 03, 2017: ConvaTec Group: Board Changes 126
6.21 Aug 03, 2017: ConvaTec Group First Half 2017 Results 127
6.22 Aug 03, 2017: Teleflex Reports Second Quarter 2017 Results 128
6.23 Aug 02, 2017: Cardinal Health Reports Q4 and Fiscal 2017 Results, Provides 2018 Guidance 130
6.24 Aug 02, 2017: Alimera Sciences Reports Second Quarter 2017 Financial Results 131
6.25 Aug 01, 2017: RMS Medical Products Closes Four-Month Period Ending June 30, 2017 with Double-Digit Percentage Growth 133
6.26 Aug 01, 2017: Fresenius confirms its guidance after a strong second quarter with double-digit sales and earnings growth 135
6.27 Jul 31, 2017: SteadyMed Appoints Jeff Myers M.D. Ph.D. Vice President of Medical Affairs 137
6.28 Jul 28, 2017: IRADIMED Announces Second Quarter 2017 Financial Results 138
6.29 Jul 26, 2017: Baxter Reports Second-Quarter 2017 Results and Provides Updated Financial Outlook for 2017 and 2020 140
6.30 Jul 25, 2017: Lilly Reports Second-Quarter Results 142
6.31 Jul 25, 2017: 3M Delivers Second-Quarter Sales of $7.8 Billion and Earnings of $2.58 per Share; Company Updates Its 2017 Outlook 146
6.32 Jul 24, 2017: MicroPort Lifesciences Attends 2017 CEA Annual Meeting 148
6.33 Jul 24, 2017: MicroPort Attends EUROPACE-CARDIOSTIM 2017 149
6.34 Jul 21, 2017: Fresenius appoints Rachel Empey as Chief Financial Officer 149
6.35 Jul 18, 2017: AngioDynamics Reports Fiscal 2017 Fourth Quarter and Full-Year Results 150
6.36 Jul 17, 2017: Baxter Appoints Cathy R. Smith to its Board 152
6.37 Jul 12, 2017: Fresenius Medical Care successfully amends and extends its credit agreement, ahead of schedule 152
6.38 Jul 07, 2017: MPSC New COO Glendy Wang on Board 152
6.39 Jul 06, 2017: Fresenius Kabi expands production site in Portugal 153
6.40 Jul 03, 2017: Cardiome's Partner SteadyMed Submits U.S. New Drug Application for TREVYENT for the Treatment of Pulmonary Arterial Hypertension 153
6.41 Jul 03, 2017: Silence Therapeutics: Issue of claim in the UK High Courts 153
7 Appendix 307
7.1 Methodology 307
7.2 About GlobalData 310
7.3 Contact Us 310
7.4 Disclaimer 310

1.1 List of Tables
Table 1: Drug Delivery Infusion Systems - Pipeline Products by Stage of Development 16
Table 2: Drug Delivery Infusion Systems - Pipeline Products by Segment 17
Table 3: Drug Delivery Infusion Systems - Pipeline Products by Territory 18
Table 4: Drug Delivery Infusion Systems - Pipeline Products by Regulatory Path 19
Table 5: Drug Delivery Infusion Systems - Pipeline Products by Estimated Approval Date 20
Table 6: Drug Delivery Infusion Systems - Ongoing Clinical Trials 21
Table 7: Infusion Systems Companies - Pipeline Products by Stage of Development 22
Table 8: Drug Delivery Infusion Systems - Pipeline Products by Stage of Development 25
Table 9: 410 Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 27
Table 10: LifeFlow Rapid Infusion Device - Severe Hemorrhage - Product Status 27
Table 11: LifeFlow Rapid Infusion Device - Severe Hemorrhage - Product Description 27
Table 12: Acuros GmbH Pipeline Products & Ongoing Clinical Trials Overview 28
Table 13: Disposable Micropump - Product Status 28
Table 14: Disposable Micropump - Product Description 28
Table 15: Adept Medical Ltd Pipeline Products & Ongoing Clinical Trials Overview 29
Table 16: Adept IVO - Product Status 29
Table 17: Adept IVO - Product Description 29
Table 18: AktiVax Inc. Pipeline Products & Ongoing Clinical Trials Overview 30
Table 19: Immunoject - Product Status 30
Table 20: Immunoject - Product Description 30
Table 21: Alnylam Pharmaceuticals Inc Pipeline Products & Ongoing Clinical Trials Overview 31
Table 22: ALN-HTT Infusion System - Product Status 31
Table 23: ALN-HTT Infusion System - Product Description 31
Table 24: AngioDynamics Inc Pipeline Products & Ongoing Clinical Trials Overview 32
Table 25: BioFlo Portline Line Extension - Product Status 32
Table 26: BioFlo Portline Line Extension - Product Description 32
Table 27: Next Generation BioFlo Port - Product Status 33
Table 28: Next Generation BioFlo Port - Product Description 33
Table 29: Power Injectable Port - Product Status 33
Table 30: Power Injectable Port - Product Description 34
Table 31: Smart Port - Dual - Product Status 34
Table 32: Smart Port - Dual - Product Description 34
Table 33: Automedics Medical Systems Inc (Inactive) Pipeline Products & Ongoing Clinical Trials Overview 35
Table 34: AutoHep System - Product Status 35
Table 35: AutoHep System - Product Description 35
Table 36: Baxter International Inc Pipeline Products & Ongoing Clinical Trials Overview 36
Table 37: Infusion Pump - Product Status 36
Table 38: Infusion Pump - Product Description 36
Table 39: Becton Dickinson and Co Pipeline Products & Ongoing Clinical Trials Overview 37
Table 40: BodyGuard Quadro - Product Status 37
Table 41: BodyGuard Quadro - Product Description 37
Table 42: BioCardia Inc Pipeline Products & Ongoing Clinical Trials Overview 38
Table 43: Helix Transendocardial Delivery System - Product Status 38
Table 44: Helix Transendocardial Delivery System - Product Description 38
Table 45: BioCardia Inc - Ongoing Clinical Trials Overview 39
Table 46: Helix Transendocardial Delivery System - A Multicentric Controlled Phase I / IIb Study Evaluating the Safety and the Efficacy of in Vitro Expanded Peripheral Blood CD34+ Stem Cells Output by the StemXpand Automated Process, and Injected in Patients with an Acute Myocardial Infarction and a Left Ventricle Ejection Fraction (LVEF) Remaining Below or Equal to 45% after PTCA and Stent(s) Implantation Versus Standard of Care 40
Table 47: Helix Transendocardial Delivery System - A Phase II, Randomized, Blinded, Study of the Safety and Efficacy of Transendocardial Injection of Allogeneic Human Mesenchymal Stem Cells (hMSCs) (20 Million or 100 Million Total MSCs) in Patients with Chronic Ischemic Left Ventricular Dysfunction Secondary to Myocardial Infarction 40
Table 48: Helix Transendocardial Delivery System - Phase I Trial of Endocavitary Injection of Bone Marrow Derived CD133+ Cells in Ischemic Refractory Cardiomyopathy (RECARDIO Trial) 40
Table 49: BioQ Pharma Inc Pipeline Products & Ongoing Clinical Trials Overview 41
Table 50: Pre-Filled Infusion System - Antibiotics - Product Status 41
Table 51: Pre-Filled Infusion System - Antibiotics - Product Description 41
Table 52: Pre-Filled Infusion System - Oncology - Product Status 42
Table 53: Pre-Filled Infusion System - Oncology - Product Description 42
Table 54: Propofol Pre-Filled Infusion System - Product Status 42
Table 55: Propofol Pre-Filled Infusion System - Product Description 43
Table 56: Ropivacaine ReadyFusOR - Product Status 43
Table 57: Ropivacaine ReadyFusOR - Product Description 43
Table 58: ClearLine MD Pipeline Products & Ongoing Clinical Trials Overview 44
Table 59: FloStat Infusion Pump System - Product Status 44
Table 60: FloStat Infusion Pump System - Product Description 44
Table 61: Debiotech SA Pipeline Products & Ongoing Clinical Trials Overview 45
Table 62: MIP Device - Product Status 45
Table 63: MIP Device - Product Description 45
Table 64: Edwards Lifesciences Corp Pipeline Products & Ongoing Clinical Trials Overview 46
Table 65: Integrated Semi-Closed Loop System - Product Status 46
Table 66: Integrated Semi-Closed Loop System - Product Description 46
Table 67: Eksigent Technologies LLC Pipeline Products & Ongoing Clinical Trials Overview 47
Table 68: External Drug Delivery System - Product Status 47
Table 69: External Drug Delivery System - Product Description 47
Table 70: Implantable Drug Delivery System - Product Status 48
Table 71: Implantable Drug Delivery System - Product Description 48
Table 72: Elcam Medical Pipeline Products & Ongoing Clinical Trials Overview 49
Table 73: Patch Pump - Product Status 49
Table 74: Patch Pump - Product Description 49
Table 75: Eli Lilly and Co Pipeline Products & Ongoing Clinical Trials Overview 50
Table 76: Drug Delivery System - Parkinson's Disease - Product Status 50
Table 77: Drug Delivery System - Parkinson's Disease - Product Description 50
Table 78: EryDel SPA Pipeline Products & Ongoing Clinical Trials Overview 51
Table 79: EryDex System - Product Status 51
Table 80: EryDex System - Product Description 51
Table 81: EryDel SPA - Ongoing Clinical Trials Overview 52
Table 82: EryDex System - Multi-center, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Effects of Intra-erythrocyte Dexamethasone Sodium Phosphate on Neurological Symptoms in Patients with Ataxia Telangiectasia 53
Table 83: Flowonix Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 54
Table 84: Implanted Drug Delivery System - Product Status 54
Table 85: Implanted Drug Delivery System - Product Description 54
Table 86: Prometra II Programmable Infusion System - Product Status 55
Table 87: Prometra II Programmable Infusion System - Product Description 55
Table 88: Flowonix Medical Inc - Ongoing Clinical Trials Overview 56
Table 89: Prometra II Programmable Infusion System - A Dose Ranging Pilot Study to Assess Intracerebroventricular (ICV) Delivery of Valproate in Subjects with Focal Seizures, with Temporal Lobe Onset with or without Secondary Generalization 57
Table 90: FluidSynchrony, LLC Pipeline Products & Ongoing Clinical Trials Overview 58
Table 91: FluidSync Pump - Product Status 58
Table 92: FluidSync Pump - Product Description 58
Table 93: Fluonic, Inc. Pipeline Products & Ongoing Clinical Trials Overview 59
Table 94: SURE+ - Product Status 59
Table 95: SURE+ - Product Description 59
Table 96: Fresenius Kidney Care Pipeline Products & Ongoing Clinical Trials Overview 60
Table 97: Intravenous 2008MeDS - Product Status 60
Table 98: Intravenous 2008MeDS - Product Description 60
Table 99: Hospira Inc Pipeline Products & Ongoing Clinical Trials Overview 61
Table 100: Smart Infusion Pump Integrated With Accelero Connect Software - Product Status 61
Table 101: Smart Infusion Pump Integrated With Accelero Connect Software - Product Description 61
Table 102: Imagnus Biomedical Inc. Pipeline Products & Ongoing Clinical Trials Overview 62
Table 103: DeltaFlow Infusion Regulator - Product Status 62
Table 104: DeltaFlow Infusion Regulator - Product Description 62
Table 105: Innovfusion Pte. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 63
Table 106: DIVA - Product Status 63
Table 107: DIVA - Product Description 63
Table 108: EPIVA - Product Status 64
Table 109: EPIVA - Product Description 64
Table 110: INTRAVA - Product Status 64
Table 111: INTRAVA - Product Description 65
Table 112: Intarcia Therapeutics Inc Pipeline Products & Ongoing Clinical Trials Overview 66
Table 113: ITCA 650 Osmotic Pump - Product Status 66
Table 114: ITCA 650 Osmotic Pump - Product Description 66
Table 115: Intarcia Therapeutics Inc - Ongoing Clinical Trials Overview 67
Table 116: ITCA 650 Osmotic Pump - A Phase IIIb, Randomized, Active Comparator, Open-label, Multicenter Study to Compare the Efficacy, Safety, and Tolerability of ITCA 650 to Empagliflozin and to Glimepiride as Add-on Therapy to Metformin in Patients with Type 2 Diabetes 68
Table 117: ITCA 650 Osmotic Pump - An Open-label, Multi-center, Randomized, Phase IIIb Study to Evaluate the Safety and Tolerability of Switching to One of Two Dosing Strategies of ITCA 650 in Patients with Type 2 Diabetes Receiving Stable Doses of Liraglutide 68
Table 118: IRadimed Corp Pipeline Products & Ongoing Clinical Trials Overview 69
Table 119: Next-generation MRI IV Pump - Product Status 69
Table 120: Next-generation MRI IV Pump - Product Description 69
Table 121: Ivenix Inc Pipeline Products & Ongoing Clinical Trials Overview 70
Table 122: Ivenix Infusion Management System - Product Status 70
Table 123: Ivenix Infusion Management System - Product Description 70
Table 124: LifeMedix, LLC Pipeline Products & Ongoing Clinical Trials Overview 71
Table 125: STATfusion - Product Status 71
Table 126: STATfusion - Product Description 71
Table 127: Lynntech Inc Pipeline Products & Ongoing Clinical Trials Overview 72
Table 128: Disposable Drug Infusion Pump - Product Status 72
Table 129: Disposable Drug Infusion Pump - Product Description 72
Table 130: Massachusetts Institute of Technology Pipeline Products & Ongoing Clinical Trials Overview 73
Table 131: Compact Self-Powered Actuator - Product Status 73
Table 132: Compact Self-Powered Actuator - Product Description 73
Table 133: Medallion Therapeutics, Inc. Pipeline Products & Ongoing Clinical Trials Overview 74
Table 134: Medallion Infusion System - Product Status 74
Table 135: Medallion Infusion System - Product Description 74
Table 136: Medical Device Creations Ltd. Pipeline Products & Ongoing Clinical Trials Overview 75
Table 137: Infusion Pump - Product Status 75
Table 138: Infusion Pump - Product Description 75
Table 139: MedPrime Technologies Pvt. Ltd. Pipeline Products & Ongoing Clinical Trials Overview 76
Table 140: InfuCheck - Product Status 76
Table 141: InfuCheck - Product Description 76
Table 142: Medtronic plc Pipeline Products & Ongoing Clinical Trials Overview 77
Table 143: SynchroMed II+ - Product Status 77
Table 144: SynchroMed II+ - Product Description 77
Table 145: Nano Precision Medical Inc Pipeline Products & Ongoing Clinical Trials Overview 78
Table 146: Nano Portal Capsule - Product Status 78
Table 147: Nano Portal Capsule - Product Description 78
Table 148: NexGen Medical Systems Inc Pipeline Products & Ongoing Clinical Trials Overview 79
Table 149: PeriCATH - Product Status 79
Table 150: PeriCATH - Product Description 79
Table 151: Nipro Corp Pipeline Products & Ongoing Clinical Trials Overview 80
Table 152: Pump For Venous Anesthesia Infusion - Product Status 80

1.2 List of Figures
Figure 1: Drug Delivery Infusion Systems - Pipeline Products by Stage of Development 16
Figure 2: Drug Delivery Infusion Systems - Pipeline Products by Segment 17
Figure 3: Drug Delivery Infusion Systems - Pipeline Products by Territory 18
Figure 4: Drug Delivery Infusion Systems - Pipeline Products by Regulatory Path 19
Figure 5: Drug Delivery Infusion Systems - Pipeline Products by Estimated Approval Date 20
Figure 6: Drug Delivery Infusion Systems - Ongoing Clinical Trials 21

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Restorative Dentistry Market by Product (Restorative Material (Glass-ionomers, Bonding Agents, Biomaterial), Implant, Prosthetic, Equipment (Handpiece, Articulator, Furnace), End User (Hospital, Clinic, Laboratory) – Global Forecast to 2027

Dental Laboratories Market by Material (Metal Ceramic, CAD/CAM Material (Zirconia, Glass Ceramic)), Equipment (Milling Equipment, CAD/CAM System, 3D Printing System, Scanner, Furnace), Prosthetics (Bridge, Crown, Veeners, Denture) – Global Forecast to 2027

Endoscope Reprocessing Market by Product (HLD and Test Strips, Detergents & Wipes, Automated Endoscope Reprocessors (AER), Endoscope Drying, Storage, & Transport Systems, Tracking Solutions), End User (Hospitals, ASCs & Clinics) (2022 – 2027)

Polymethyl Methacrylate (PMMA) Market by Grade (General Purpose, Optical), Form(Extruded Sheet, Cast Acrylic Sheet, Pellets, Beads),End-Use Industry(Signs & Displays, Construction, Automotive, Lighting Fixtures, Electronics, Marine, Healthcare) & Region – Global Forecast to 2027

Microtome Market by Product (Instruments, (Rotary), Accessories (Microtome Blades), Application (Disease Diagnosis, Medical Research), Technology (Fully Automated, Semi-automated, Manual), End User (Hospital, Clinical Labs) – Global Forecast to 2027